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Study Evaluating MAC-321 in C...

Study Evaluating MAC-321 in Colorectal Cancer

Last Updated: 2009-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2004-02-29

Brief Summary

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Assess the clinical activity of MAC-321 administered IV as a second-line or third-line antineoplastic agent to subjects with advanced colorectal cancer. Clinical activity will be assessed by determining the percentage of subjects exhibiting an objective response (complete plus partial responses). Tumor response will be assessed following modified Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.

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Detailed Description

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Conditions

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Colorectal Neoplasms Colonic Neoplasms Rectal Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MAC-321

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologic and/or cytologic diagnosis of metastatic or relapsed colorectal cancer at any time during disease but not candidates for surgical resection.
* Prior treatment with at least 1 conventional approved therapeutic regimen.
* Subjects who have failed prior cytotoxic chemotherapy regimens containing irinotecan (CPT-11), 5 fluorouracil (5-FU), and/or oxaliplatin for advanced (relapsed) metastatic colon cancer are eligible

Exclusion Criteria

* Other chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks before signing the ICF (6 weeks if the previous chemotherapy included nitrosoureas or mitomycin)
* Prior radiotherapy to \>25% of bone marrow
* Prior exposure to MAC-321

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers